NextAR Knee Platform 15.8020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345731661), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Difficult or Delayed Positioning

  DURING SURGERY, THE DISTAL FEMORAL CUT WAS REPORTED AS NOT STRAIGHT FORWARD, WITH AN INITIAL UNDER-RESECTION OF APPROXIMATELY 3D 4 MM COMPARED TO THE PLAN. ADDITIONAL CUTS WERE SUBSEQUENTLY PERFORMED; BOTH DISTAL AND POSTERIOR FEMORAL CUTS WERE ULTIMATELY ALIGNED WITH THE PREOPERATIVE PLANNING AND VERIFIED WITH A CALIPER. THE TIBIAL CUT WAS PERFORMED AS PLANNED. DESPITE THIS, POST-RESECTION ASSESSMENT REVEALED AN IMBALANCE IN BOTH FLEXION AND EXTENSION. WHEN USING THE PLANNED 10 MM POLYETHYLENE SPACER, THE SURGEON OBSERVED LAXITY IN BOTH PHASES, LEADING TO THE USE OF A 13 MM INSERT TO IMPROVE STABILITY. HOWEVER, WITH THE 13 MM TRIAL, THE KNEE BECAME TOO TIGHT IN EXTENSION WHILE REMAINING LAX IN FLEXION. A VALGUS RECUT WITH ADDITIONAL BONE RESECTION WAS THEN PERFORMED, ALTHOUGH NO MEASUREMENTS OF THE RESECTION DEPTH ARE AVAILABLE, AND THIS APPROACH APPEARS UNUSUAL GIVEN THE PRESENCE OF MEDIAL INSTABILITY. THE MEDIAL COMPARTMENT WAS REPORTED TO BE HIGHLY LAX, AS ALSO INDICATED BY NEXTAR. DUE TO PERSISTENT INSTABILITY AND PATIENT-RELATED FACTORS, A REVISION TIBIAL COMPONENT WITH WEDGES WAS IMPLANTED. THE OVERALL SURGICAL TIME INCREASED BY APPROXIMATELY 50 MINUTES. CASE CODE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711334 ↗